What Was Approved?
On May 27, 2026, the U.S. Food and Drug Administration approved Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with blastic plasmacytoid dendritic cell neoplasm, or BPDCN.
BPDCN is a rare and aggressive blood cancer that can involve the bone marrow, blood, skin, lymph nodes, and other organs.
What Is Decnupaz?
Decnupaz is a CD123-directed antibody-drug conjugate.
It is designed to bind to CD123 on certain cancer cells and deliver an attached cell-damaging drug into those cells.
How Is Decnupaz Given?
The recommended dose is:
0.045 mg/kg by intravenous infusion once every three weeks.
Treatment generally continues until the disease progresses or unacceptable toxicity occurs.
Patients also receive medications before the infusion to help reduce the risk of infusion-related reactions.
What Did the Clinical Trial Show?
FDA evaluated Decnupaz in the CADENZA clinical trial.
Among 33 patients who had not previously been treated for BPDCN, about 70% achieved complete remission or clinical complete remission.
Among 51 patients whose disease had returned or had not responded to previous treatment, about 16% achieved complete or clinical complete remission.
These results describe the study population and do not predict how an individual patient will respond.
Does Decnupaz Have a Boxed Warning?
Yes.
Decnupaz carries a boxed warning for serious liver toxicity, including hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome.
Severe and fatal cases have occurred.
The FDA label recommends liver testing and monitoring before each dose, and Decnupaz should be discontinued if VOD develops.
What Other Safety Issues Are Important?
The prescribing information also includes warnings for:
- Infusion-related reactions
- Edema
- Sulfite allergic reactions
- Embryo-fetal toxicity
The FDA label also advises avoiding use in patients with moderate to severe kidney or liver impairment.
Bottom Line
Decnupaz (pivekimab sunirine-pvzy) is a newly FDA-approved intravenous treatment for adults with BPDCN.
It provides a new targeted treatment option for this rare blood cancer, but it carries an important boxed warning for serious liver injury, including potentially fatal hepatic VOD.
Treatment requires specialist supervision and careful monitoring.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Approves Pivekimab Sunirine-pvzy for Blastic Plasmacytoid Dendritic Cell Neoplasm, May 27, 2026.
- U.S. Food and Drug Administration (FDA) — Decnupaz (pivekimab sunirine-pvzy) Prescribing Information, May 2026.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Decnupaz.